Tolerance and Pharmacokinetics Study of MNTX Tablets

A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01366339

Enrollment

Registered

2011-06-06

Start date

2003-10-31

Completion date

2003-12-31

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Healthy Volunteers

Brief summary

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Interventions

DRUGOral methylnaltrexone

DRUGOral placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Weight between 55 and 85 kg 2. In good health with no evidence of a clinically significant chronic medical condition 3. Non-Smokers.

Exclusion criteria

1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder 2. Known or suspected hypersensitivity to opioids or opioid antagonists 3. History or suspicion of alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax) of oral doses of MNTX	7 days	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

Secondary

Measure	Time frame	Description
Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX	7 days	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX	7 days	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Half-life of oral doses of MNTX	7 days	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026